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Aclovate (Alclometasone Dipropionate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ACLOVATE® Cream and Ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ACLOVATE® Cream and Ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use). Since the safety and efficacy of ACLOVATE® Cream and Ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.

DOSAGE AND ADMINISTRATION

Apply a thin film of ACLOVATE® Cream or Ointment to the affected skin areas 2 or 3 times daily; massage gently until the medication disappears.

ACLOVATE® Cream and Ointment may be used in pediatric patients 1 year of age or older. Safety and effectiveness of ACLOVATE® Cream or Ointment in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

ACLOVATE® Cream or Ointment should not be used with occlusive dressings unless directed by a physician. ACLOVATE® Cream or Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with ACLOVATE® Cream or Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

HOW SUPPLIED

ACLOVATE® (alclometasone dipropionate cream) Cream, 0.05% is supplied in:

  •   15-g tubes (NDC 0462-0263-15), and
  •   60-g tubes (NDC 0462-0263-60).

ACLOVATE® (alclometasone dipropionate ointment) Ointment, 0.05% is supplied in:

  •   15-g tubes (NDC 0462-0264-15), and
  •   60-g tubes (NDC 0462-0264-60).

Store between 2° and 30°C (36° and 86°F).

PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com

R4/11

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